The following data is part of a premarket notification filed by Ningbo Huahui Medical Instruments Co., Ltd. with the FDA for Clinical Electronic Thermometers, Model(s) Mt901, Mt518, Ect-1.
| Device ID | K072635 |
| 510k Number | K072635 |
| Device Name: | CLINICAL ELECTRONIC THERMOMETERS, MODEL(S) MT901, MT518, ECT-1 |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | NINGBO HUAHUI MEDICAL INSTRUMENTS CO., LTD. SUITE 8D, NO. 19 LANE 999 Shanghai, CN 200030 |
| Contact | Diana Hong |
| Correspondent | Diana Hong NINGBO HUAHUI MEDICAL INSTRUMENTS CO., LTD. SUITE 8D, NO. 19 LANE 999 Shanghai, CN 200030 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-18 |
| Decision Date | 2008-01-17 |
| Summary: | summary |